Spots Global Cancer Trial Database for Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer

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Trial Identification

Brief Title: Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer

Official Title: Phase IB Open-Label Rising-Dose Study of Biomed 101 in Patients Treated With Interleukin-2 for Malignancy

Study ID: NCT00004890

Conditions

Drug Extravasation

Kidney Cancer

Interventions

aldesleukin

Biomed 101

Study Description

Brief Summary: RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. Biomed 101 may protect normal cells from the side effects of interleukin-2. PURPOSE: Phase I trial to study the effectiveness of Biomed 101 in treating patients receiving interleukin-2 for kidney cancer.

Detailed Description: OBJECTIVES: I. Evaluate the safety and maximum tolerated dose of Biomed 101 in patients with renal cell cancer currently treated with interleukin-2 (IL-2). II. Evaluate the effect of different doses of Biomed 101 on the incidence and severity of IL-2 related toxicities and on the incidence and frequency of IL-2 dose reduction due to IL-2 induced toxicity. OUTLINE: This is a dose escalation study of Biomed 101. Patients receive oral Biomed 101 three times daily, followed by interleukin-2 IV on days 1-5 and 16-20. Cohorts of 5 patients receive escalating doses of Biomed 101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose limiting toxicities. Patients are followed for 1 month. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.